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It decreases gastric emptying time, meaning the stomach empties more quickly after the administration of ginger
The dosing schedule includes a 2-month hiatus during the fifth and sixth months, corresponding with the continuation of gastric balloon therapy during a total 6-month period
This included contaminated vials or improperly mixed solutions that worsened their conditions
Therefore, although the applicant suggests otherwise, this data did not follow a statistical distribution similar to that considered for rarely-utilized orphan drugs meeting the criteria at 414.940(d)(5), which may not have a normal statistical distribution from quarter to quarter, potentially resulting in highly variable refund amounts as compared with the variability of drugs administered to a higher number of beneficiaries
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